study of antivascular therapy combined with chemotherapy versus chemotherapy in adjuvant therapy of tnbc-blis patients (bctop-t-a03)

Conditions: Breast Cancer; Triple Negative Breast Cancer

Summary: this is a randomized, open-label phase iii clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/immune suppressed subtype.


Eligibility criteria:
inclusion criteria: * women aged 18-70 years old; * eastern oncology collaborative group (ecog) physical status score: 0 or 1; * histological results recorded as tnbc (negative her2, er, and pgr status) and blis subtype according to the classification of fuscc; * have stage iia-iiiic triple-negative breast cancer with non-metastatic surgically treated: pt1-3n1-3m0; * adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (anc) ≥ 1500 cells/μl (no g-csf support therapy within 2 weeks prior to day 1 of course 1); platelet count ≥ 75×109/l (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dl (no rbc transfusion within 2 weeks before day 1 of course 1); ast, alt, and alkaline phosphatase ≤ 3 × upper limit of normal (uln) serum total bilirubin ≤ 1.0 × uln; serum creatinine ≤ 1uln and with an endogenous creatinine clearance rate of \>50 ml/min (cockcroft-gault formula); * the surgical incision had fully healed prior to the commencement of the study; * female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug; * sign the informed consent form (icf). the patient is judged by the investigator to have the ability to comply with the provisions of the protocol. exclusion criteria: * has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy) * has bilateral breast cancer; * has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. * has metastatic (stage 4) breast cancer; * has any \>t4 lesion (uicc1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); * has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (lvef) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; * is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives; * patients participating in other clinical trials at the same time; * has known allergy to taxane and excipients. * has severe or uncontrolled infection; * has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders; * the researchers judged patients to be unsuitable for the study.

Keywords: triple negative breast cancer adjuvant therapy antivascular therapy